Ezekial Emanual, Chief of Bioethics NIH

1
Ezekial Emanual, Chief of Bioethics NIH

• Simple idea justice requires treating everyone,
  everywhere in exactly the same way
• Justice requires no such thing. It simply
  requires us to treat people fairly.
• If rules of clinical trials require participants
  to receive the best care on earth, there would be
  no clinical trials.

2
Marcia Angel

• Medical ethics has no borders
• What is morally right in America is morally right
  in Africa, too
• International rules of medical expt. require
• Volunteers in vaccine trial receive best
  treatment available, NOT level of care in poor
  country
• People are not guinea pigs. Research must hold
  human welfare above interest of society and
  science. If you dont, youre on a slippery slope
  where first humans are exploited for worthwhile
  purposes, then for not so worthwhile purposes.

3
Peter Lurie

• Fears scientists will use poor quality of care
  available in Africa to do what they want
• You are not permitted to use subjects to collect
  data just because it is useful to you
• That is exploitation and abuse
• That is what Tuskegee was
• Scientists will withhold treatments they know
  will work in the name of science
• Will be greatest injustice in hx of medicine
• Tests of AZT proved there was a two-tiered
  standard for health care in the world
• One set of rules for rich people, and another for
  those who are poor

4
Andrew McMichael

• Abhors hype
• Rarely discusses his vaccine work without saying
  it all might come to nothing
• First vaccine to target specific viral subtype
  most prevalent in East Africa
• Might require frequent booster shots

5
Sarah Rowland-Jones

• Infectious disease specialist
• First vaccine to target specific viral subtype
  most prevalent in East Africa
• Might require frequent booster shots

6
Pontiano Kaleebu

• We have asked Ugandans to be guinea pigs before.
  We have not come back to say, Here is your
  reward.
• Worried that question of whether trials can be
  done fairly and ethically, will overshadow
  science
• We will give people the best care we can afford.
  That is fair.
• If I could distribute anti-retroviral drugs, I
  would be thrilled. But, I dont see how and I
  dont see when. And the debate is a bit
  patronizing.
• This is not an issue of individual rights. It is
  a public health emergency.
• I never though AIDS would be in my children's
  futures. I have come to realize that now. And
  it frightens me.

7
Edward Mbidde, Uganda Cancer Inst.

• Last 15 years have best Uganda has seen
• We have leadership, support, we are united
• If we need to go to work and we cannot afford a
  Mercedes Benz, should we refuse to ride a
  motorcycle? Or should we get there by the best
  route we have?
• Principles matter to us as much to us as they do
  to Americans. But we have been dying for a long
  time, and you cannot respond to death with
  principles.

8
Seth Berkley

• You have to ask yourself what on earth the people
  on this planet are doing
• In the end only a vaccine will matter
• There is no incentive for companies to make
  vaccines
• Society cant get it together. These trials cost
  hundreds of millions of dollars. How do we pay
  for it?

9
Don Francis

• Would be pleased if vaccine worked 1/3 of the
  time
• If his vaccine is introduced and proven
  effective, no other vaccines can be tested
  against placebo

10
Ugandan Medical Student

• Would it be fair for village people to enter
  trial if those who became infected did not get
  anti-retroviral drugs?
• Indicated missing medical supplies aspirin,
  basic antibiotics
• We do not get the care you get. We never will.
  But I would line up tomorrow to test anything
  that might help us in any way. And I am sure the
  rest of the village would too.

11
Larry Corey

• Lets be realistic for 5 minutes
• To create a vaccine that works 40 of the time,
  costs 1,000, and requires that you go to the lab
  to get a blood test every 6 weeks is crap
• We need a 90 biologically active product with no
  side-effects that costs at most 150-200.
• We are asking the Third World to take risks that
  we have never taken ourselves
• Every other time that we have gone in with a
  vaccine, we have been able to say, It works on
  our people.
• Now I have to say I have no idea if I have
  schlock or I have gold. But you need it and we
  need it, so we will have to test it on you.